510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991594Substantially Equivalent

Celsior Cold Flush, Storage and Transport Solution for Hearts

Sangstat Medical Corp., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991594 is the FDA 510(k) clearance record for CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS, a class II device, cleared for Sangstat Medical Corp. on under FDA product code MSB (System And Accessories, Isolated Heart, Transport And Preservation). FDA records list 3 510(k) clearances for Sangstat Medical Corp., from to . As of , FDA records show one recall naming K991594.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MSB System And Accessories, Isolated Heart, Transport And Preservation
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sangstat Medical Corp. 6300 Dumbarton Cir., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code MSB

Trailing 12 months
1 clearance under product code MSB in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260